Quality Assurance - Batch Related Documents

If you are you a meticulous and driven Quality Assurance professional looking to make a significant impact, Randstad is looking for qualified professionals to work onsite with their client in RTP. In this position, you will have an opportunity to work in a well-respected Biotechnology company AND have the support you need with a career coach guiding you towards success :)

PLEASE DO NOT APPLY if you live outside the Raleigh-Durham area as this role is 100% onsite.

Who You Are:

You're an individual with 2+ years of experience within a biopharmaceutical or highly regulated environment.

You possess a keen eye for detail and a strong commitment to quality.

You're proactive, eager to learn, and thrive in an environment where your contributions directly support groundbreaking science.

What You'll Do:

Be a Guardian of Quality: Meticulously review GMP raw data for compliance, ensuring the integrity of our processes and products with your review and approval of batch related documentation (Solution Lot records, Reports, Logbooks and Release of Autoclaved Equipment).

Transport batch related documentation across RTP buildings supporting chain of custody and life cycle management.

Ensure Compliance Excellence: Support the resolution of technical and compliance issues/gaps.

Collaborate and Grow: Partner with key Quality and Manufacturing teams, gaining exposure to diverse aspects of biopharmaceutical production and contributing to the day-to-day implementation of cGMP.

Assist in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, ensuring the safety, efficacy and purity of the products.

Logistics & Life Cycle Management: Secure transport of critical batch documentation, supporting seamless chain of custody.

Opportunity to contribute to projects.

Preferred Professional Experience:

2-5 years' experience as a QA associate within a large molecule, drug substance facility

Regulatory requirements in the pharmaceutical industry (FDA, EMA)

Able to manage multiple tasks in a fast-paced environment

Education:

Bachelor’s degree in science or other related field of study